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Name:
UMIN ID:

Recruitment status
Unique ID issued by UMIN UMIN000025469
Receipt No. R000029292
Scientific Title Effect of gastric acid suppression by use of vonoplazan
Date of disclosure of the study information 2016/12/31
Last modified on 2017/01/06

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Basic information
Public title Effect of gastric acid suppression by use of vonoplazan
Acronym Effect of gastric acid suppression by use of vonoplazan
Scientific Title Effect of gastric acid suppression by use of vonoplazan
Scientific Title:Acronym Effect of gastric acid suppression by use of vonoplazan
Region
Japan

Condition
Condition healthy person
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of gastric acid suppression by use of vonoprazan
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes gastric acid secretion (1day before administration, 6 days in administration, 3days after administration)
Key secondary outcomes Serum gastrin levels

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 administration of vonoprazan
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
45 years-old >
Gender Male
Key inclusion criteria (1)Healthy Japanese adult males.
(2)Between the ages of 20-45 at the time of informed consent.
(3)Subjects signed informed consent form voluntary.
Key exclusion criteria (1)Subjects with history of gastric ulcer or duodenum ulcer
(2)Subjects with a serious complication of liver failure
(3)Subjects with a serious complication of renal failure
(4)Subjects with a serious complication of heart failure
(5)Subjects treated with atazanavir sulfate (Reyataz) or rilpivirine hydrochloride (Edurant)
(6)Subjects with Zollinger-Ellison syndrome
(7)Subjects with history of surgery that affects gastric-acid secretion
(8)Subjects with a history of allergy to the investigational product
(9)Subjects with atrophic gastritis, gastric tumor, gastric ulcer or duodenum ulcer by endoscopic examination.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Mototsugu Kato
Organization National Hospital Organization Hakodate Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL +81-0138-51-6281
Email mkato1957@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Mototsugu Kato
Organization National Hospital Organization Hakodate Hospital
Division name Department of Gastroenterology and Hepatology
Zip code
Address 16-gou, 18-banchi, Kawahara-chou, Hakodate, 041-8512, Japan
TEL +81-0138-51-6281
Homepage URL
Email mkato1957@gmail.com

Sponsor
Institute National Hospital Organization Hakodate Hospital
Institute
Department

Funding Source
Organization Eisai Co., Ltd.; Takeda Pharmaceutical Co., Ltd.; Daiichi Sankyo Co., Ltd.; and AstraZeneca K.K. and Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2016 Year 11 Month 14 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 29 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 29 Day
Last modified on
2017 Year 01 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029292

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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